DBV: EMA PDCO Gives Positive Opinion On PIP For Viaskin Peanut - Quick Facts

(RTTNews) - DBV Technologies (DBVT), a clinical-stage specialty biopharmaceutical company, announced Thursday that the Pediatric Committee or PDCO of the European Medicines Agency or EMA adopted a positive opinion agreeing the company's PIP for Viaskin Peanut.

DBV, which is developing allergy treatment Viaskin, noted that the acceptance of this Paediatric Investigation Plan or PIP paves the way for the potential submission of a Marketing Authorization Application or MAA in Europe following completion of the Viaskin Peanut Phase III program.

As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in pediatric population. The company noted that an accepted PIP is a prerequisite for the filing for marketing authorization for any new medicinal product in Europe.

DBV's PIP provides a comprehensive clinical development plan for Viaskin Peanut in pediatric population from 1 to 17 years of age, in particular the features of the phase III program in children.

Pierre-Henri Benhamou, Chairman and CEO of DBV, said, "This PIP acceptance is the first regulatory milestone in Europe for Viaskin Peanut.... We are now well positioned to focus on the launch of our Viaskin Peanut Phase III trial in children."

Viaskin Peanut is currently being investigated in clinical trials for treatment of peanut allergy.